This article is the third in-depth analysis dedicated to Restriction 78 on synthetic polymer microparticles (SPM). In the previous articles, we analysed the scope of the restriction and the main derogations.
First of all, the requirements described in this article apply only to products falling under the derogation provided for in paragraph 4(a), namely SPM intended to be used at industrial sites.
“Industrial sites” include, for example, production and processing sites, construction and assembly sites, or sites where large-scale maintenance and repair activities are carried out. These are generally environments characterised by highly automated processes and engineered control systems requiring authorisations in accordance with the Industrial Emissions Directive (IED).
What information must be included in the SDS?
Paragraph 7 of Entry 78 of Annex XVII to REACH provides that, from 17 October 2025, suppliers of SPM referred to in paragraph 4(a) must provide the following information:
a) instructions for use and disposal, to prevent the release of synthetic polymer microparticles into the environment;
b) statement on Restriction 78: “The synthetic polymer microparticles supplied are subject to the conditions laid down in Annex XVII, Entry 78, to Regulation (EC) No 1907/2006 of the European Parliament and of the Council.”
c) the quantity or concentration of synthetic polymer microparticles (SPM) contained in the substance or mixture (e.g. “16 g of polymer X per 40 ml of product” or “40% w/w of polymer Y”);
d) the identity of the polymers, as provided for in Entry 78, to enable manufacturers and downstream users to comply with the relevant obligations, including reporting obligations.
Paragraph 10 of the Restriction specifies that the information referred to in paragraph 7 must be provided in the safety data sheet (SDS).
In which sections of the SDS should the information be included?
a) IFUD → the instructions for use and safe handling can be included in Section 7 – Handling and storage, while disposal instructions can be included in Section 13 – Disposal considerations.
For the correct drafting of IFUD in the SDS, the supplier should:
- Take into consideration the industrial user of the product. For example, it should be assumed that instructions on how to handle, store and dispose of the product in an industrial context may differ from those applicable in a professional or consumer context.
- Ensure that the information is clear and self-explanatory: avoid referring to regulations or references that the downstream user must look for outside the safety data sheet.
- Ensure that the instructions are practicable: if the instructions are so complex that they cannot be applied, the supplier should consider the possibility of not placing the product on the market because SPM emissions cannot be reduced.
b) the statement relating to Restriction 78 can be included in Section 15 – Regulatory information, where regulatory information concerning the product and the substances contained in it is normally provided;
c) the quantity or concentration of SPM can be indicated in Section 15, specifying the exact value or, where appropriate, a realistic range (and taking into account the fact that downstream users will have to use the upper limit of that range in their documentation);
d) the identity of the polymers contained can also be included in Section 15. A generic description of the polymer is sufficient (e.g. polyethylene terephthalate (PET)). This will be used by the downstream user for reporting on the platform provided by ECHA (a list of entries to choose from will be available). It is not necessary to provide the exact details of the polymer identity.
The key point is that all the required information must be present in the SDS and easily accessible.
Q&A
If SPM are indicated in Section 15 of the SDS but not in Section 3, is this a problem?
Not necessarily. The presence of a polymer in a mixture does not automatically imply an obligation to include it in Section 3 of the SDS.
For the purposes of Restriction 78, what matters is that the information required under paragraph 7 is correctly available in the SDS.
Is any polymer automatically subject to Restriction 78?
No. The presence of a polymer does not automatically mean that Restriction 78 applies.
Entry 78 applies to synthetic polymer microparticles that meet the characteristics and conditions laid down by the Regulation, including those relating to particle size and concentration.
Is it possible to include the required information in different sections of the SDS?
Yes. The legislation establishes which information must be provided, but does not require each individual piece of information to be included in a specific SDS section.
The information can therefore be distributed among the most appropriate sections, provided that it is complete, consistent and easily accessible.
How to Manage Restriction 78 in the SDS?
Entering and updating information relating to microplastics can become particularly challenging when managing numerous formulations and SDSs.
SDS management software allows data to be centralised and the generation and updating of safety data sheets to be automated, helping companies keep the requirements set out by REACH, CLP and GHS under control.
